Inhalation therapy assembly and method

ABSTRACT

The inhalation therapy assembly and method of use described herein increases the efficiency of metered dose inhalers by allowing delivery of the doses to a collapsible reservoir which can be manually pumped, ensuring that medicants contained therein are properly and completely delivered to the patient. Terminal and proximal valves of the one-way diaphragm type allow flow of the aerosol medicants while preventing improper expulsion. An exhalation valve is adjustable to ensure the patient exhales suitably to permit proper medicant absorption. A conventional metered dosage inhaler having an approved FDA canister provides proper dosage to the patient and is joined to the collapsible reservoir by a connector having a plurality of apertures for receiving the MDI and an accessory T-fitting.

This is a continuation-in-part of patent application Ser. No. 09/730,997filed Dec. 7, 2000 now U.S. Pat. No. 6,494,202.

FIELD OF THE INVENTION

The invention herein pertains to inhalation therapy and particularlypertains to an assembly and method which utilizes a manual pumpingaction to ensure complete medication dosage delivery to the patient.

DESCRIPTION OF THE PRIOR ART AND OBJECTIVES OF THE INVENTION

Medications for bronchitis and other common respiratory ailments areconventionally sold in metered dose inhalers (MDI) which havepressurized canisters to release a prescribed dosage quantity ofmedicants upon each manual activation. Many patients frequently use MDIsfor easy, portable, self-medication. Other patients with more serioushealth conditions utilize various types of inhalation therapy devicessuch as set forth in U.S. Pat. Nos. 5,020,530 and 5,479,920. Inaddition, U.S. Pat. No. 5,842,467 provides a MDI in combination with amanual breathing unit. Other common types of mechanical respiratorydevices include electrical powered ventilators, oxygen tanks and thelike.

It is commonplace to utilize a collapsible reservoir with an MDIcanister for discharge therein. Such devices are often used inventilator breathing circuits. It is also usual to provide a rigid,transparent, cylindrical reservoir with a MDI canister for containmentof the medicants before such enters the patient's lungs.

Conventional methods of delivering respiratory medicants often work verywell under normal circumstances with a cooperative patient. However,young children are often frightened by inhalation apparatus which areattached to their face and as a result hold their breath, preventingintake of the medicants. Sometimes elderly patients become obstinate andwill not cooperate with medical personnel or some, for physical reasonshave difficulty in breathing properly. Breathing too fast can also causeproblems in that the medicants are taken into the lungs and are exhaledtoo quickly, before being absorbed. Under these conditions the medicantsare not absorbed and the patient does not ultimately benefit from theprescribed dosage. Other patients also lack adequate muscle tone fordeep breaths due to advanced disease status or heavy sedation.

Thus, with the problems and difficulties of prior art inhalation therapydevices, the present invention was conceived and one of its objectivesis to provide an inhalation therapy assembly and method which willconveniently and easily allow the patient to receive the properprescribed medicant dosage.

It is also an objective of the present invention to provide aninhalation assembly which can be used with either a facial mask or anendotrachael tube.

It is yet a further objection of the present invention to provide aninhalation therapy assembly which includes a collapsible reservoir whichcan be used to manually pump medicants to the patient.

It is still another objective of the present invention to provide aninhalation therapy assembly which utilizes a standard peep valve whichis adjustable to provide the needed resistance for a particular patient.

It is a further objective of the present invention to provide analternative inhalation therapy assembly and method utilizing aconventional MDI which can be connected to an inhalation therapyassembly having a collapsible reservoir to ensure FDA approved dosageamounts.

Various other objectives and advantages of the present invention willbecome apparent to those skilled in the art as a more detaileddescription is set forth below.

SUMMARY OF THE INVENTION

The aforesaid and other objectives are realized by providing aninhalation assembly which includes a MDI canister housing which isaffixed to a conventional coil spring supported, transparent, flexiblereservoir for receiving medicants therefrom. In an alternate embodimenta commercially available MDI and cannister is utilized. As the medicantsare released from the pressurized aerosol canister, such medicants flowinto the expanded reservoir and a terminal diaphragm valve incommunication therewith closes due to the pressure associated therewith.As the patient breathes in, a proximal one-way valve on the reservoiropens to allow the medicants to flow from the reservoir to the lungs ofthe patient through a means connected to a delivery tube, either anendotracheal tube or a conventional facial mask. An adjustableexhalation valve prevents the patient from over breathing, i.e.,expiring the medicants too quickly. Should there be a problem with thepatient's breathing, through either lack of cooperation, fear orvoluntary physical restraints, the assisting medical personnel cansimply “pump” the assembly manually by urging the reservoir to acollapsed position, thereby driving the medicants from the reservoirthrough the proximal one-way valve into the delivery tube which isattached to for example, a facial mask. The reservoir, which is springloaded will then recover and the pumping action is repeated until allthe medicants are introduced into the patient's lungs, thereby ensuringthe patient of receiving the full dosage prescribed, without significantresidual amounts remaining in the reservoir.

In an alternate embodiment, a typical metered dose inhaler andpressurized canister is employed to insure FDA approved doses aredelivered. An MDI canister is thereby releasably joined to the terminalend of a cylindrical reservoir by a connector which includes an aperturefor the outlet of the MDI and for an accessory T-fitting for supplyingsupplemental oxygen, if needed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a top view of the preferred form of the invention with thereservoir in an extended state;

FIG. 2 illustrates the invention as shown in FIG. 1 but with thereservoir in a collapsed posture;

FIG. 3 depicts an enlarged partial side view of the reservoir and MDIcanister housing;

FIG. 4 pictures the apparatus as shown in FIG. 1 in place on a malepatient;

FIG. 5 shows an alternate inhalation therapy assembly for use with aconventional MDI;

FIG. 6 depicts a view of the fragmented assembly as seen in FIG. 5 inenlarged fashion;

FIG. 7 illustrates an end view of the MDI connector as seen in FIG. 6along lines 7—7; and

FIG. 8 demonstrates the inhalation therapy assembly as seen in FIG. 6but with the MDI and accessory T-fitting attached.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT AND OPERATION OF THEINVENTION

For a better understanding of the invention and its operation, turningnow to the drawings, FIG. 1 illustrates preferred inhalation therapyassembly 10 having an aerosol metered dose inhaler (MDI) canister 11positioned in receptacle 15 of MDI housing 12 for delivering medicants22 through housing channel 13 (FIG. 3) into collapsible reservoir 14.Standard terminal one-way diaphragm valve 16 is in fluid communicationwith collapsible reservoir 14 to prevent fluids contained withinreservoir 14 from escaping and to allow entry of air into reservoir 14as it is expanded. At the other end of reservoir 14, proximal one-waydiaphragm valve 19 is connected to T-shaped delivery tube 17 as seen inFIGS. 1 and 2. T-shaped delivery tube 17 provides a passageway fordirecting medicants 22 to patient 20 (FIG. 4) through a means to connectto a patient, preferably mask 18. As aerosol medicants 22 are often notdirectly or efficiently delivered to patient 20, collapsible reservoir14 can be manually collapsed and extended (pumped) in order to ensuresubstantial delivery of medicants 22 to patient 20. This is ofparticular importance for very young patients that might hold theirbreath or older patients that are uncooperative or lack sufficientmuscle tone for a full spontaneous inhalation. Collapsible reservoir 14is conventional and includes an outer, thin, transparent, polymeric wall23 which is internally supported by metal coil spring 24 as seen in FIG.3.

After patient 20 inhales medicants 22 from reservoir 14, exhaled gasesare then forced through T-shaped delivery tube 17 and encounterexhalation or peep valve 21 as shown in FIG. 2 which provides resistanceto the exhaled gases, as proximal valve 19 is closed. This createdresistance increases the time medicants 22 remain in the lungs ofpatient 20 and assists in the absorption thereof.

The preferred method of use of inhalation assembly 10 comprisesattaching mask 18 to patient 20 via straps 25 or the like which may havea means to connect thereon such as hook and loop fasteners, a buckle,snaps or the like (not seen). Next, MDI canister 11 is positioned inreceptacle 15 of housing 12 with reservoir 14 fully expanded as shown inFIG. 1. By depressing aerosol MDI canister 11 within receptacle 15 theMDI canister valve (not shown) opens, and medicants 22 contained thereinwhich may be for the treatment of bronchitis or other ailments passesthrough channel 13 into collapsible reservoir 14. Normal breathing bypatient 20 draws medicants 22 from reservoir 14 through mask 18 and oninto the lungs of patient 20 as intended. After inhaling, patient 20then exhales and one-way proximal diaphragm valve 19 as shown in FIGS. 1and 2 prevents exhaled gases from entering reservoir 14. Rather, suchgases are passed through standard exhalation valve 21 which has beenadjusted for suitable resistance, depending on the specific requirementsof patient 20. For example, if the patient is breathing normally, thenvalve 21 would be positioned at a relative low rating (such as at 5 cmof water pressure). This setting would also be used when assembly 10 isused with an endotracheal tube. For a greater resistance, that is, toprevent the patient from exhaling too quickly and the medicant 22 beingonly partially absorbed due to the short time period in the lungs,exhalation valve 21 is adjusted for a greater resistance, up to forexample, 20 cm of water pressure. This high resistance slows theexhalation of the patient, thereby allowing the medicants to be morefully absorbed.

In the event a patient is uncooperative, or has trouble breathing oncemedicants 22 have been released into reservoir 14, a nurse or othermedical personnel can manually “pump” reservoir 14 by grasping canisterhousing 12 and urging reservoir 14 into a collapsed posture as shown inFIG. 2. Terminal valve 16 which has been closed by the pressure createdin reservoir 14 by the release of medicants 22 from pressurized aerosolMDI canister 11, remains closed as reservoir 14 is collapsed. Oncecollapsed, reservoir 14 can be rapidly expanded by manually urging itoutwardly, which allows terminal valve 16 to open and permits air toflow therethrough into reservoir 14. As would be understood, proximalone-way valve 19 likewise opens as air is forced therethrough bycollapsing reservoir 14 and allows medicants 22 to pass into T-shapeddelivery tube 17 and on to patient 20. Additional collapsing andexpansion of reservoir 14 can be carried out as required and, ifadditional doses of medicants 22 are needed, MDI canister 11 is manuallypressed downwardly to release medicants 22 therefrom into reservoir 14as hereinbefore explained.

Thus, inhalation assembly 10 provides an easy method for ensuring bothmedicant delivery and absorption by patient 20. Also, the device isconveniently used with patients requiring an endotracheal tube (notseen) which is attached to T-shaped delivery tube 17 in place of mask18.

In an alternate embodiment of the invention as shown in FIGS. 5-8,alternate inhalation therapy assembly 30 is shown in FIG. 5 having aseparately furnished standard aerosol metered dose inhaler (MDI) 31 withcanister 32 therein. Metered dose inhaler 31 is produced by a number ofpharmaceutical companies and is manually operated by depressing canister32 to deliver a specific, FDA approved dosage of medicants throughnozzle 37 (FIG. 6). Connector 33 formed from plastic with a somewhatresilient or flexible, circular adapter 36 surrounding opening 38 isaffixed to collapsible reservoir 35 which performs in the same manner aspreviously described regarding collapsible reservoir 14 of the preferredembodiment. Connector 33 as shown in FIG. 7 includes aperture 38 forreceiving nozzle 37 of MDI 31 as shown in FIG. 6 and also includes inlet39 with one-way valve 41 (FIG. 8) which can be used for receivingaccessory T-fitting 40 (shown in FIGS. 6 and 8). T-fitting 40 may beused for an auxiliary oxygen supply hook-up. Flap valve 41 closes asreservoir 35 is collapsed. Thus, flap valve 41 is normally closed andhelps prevent the escape of medicants from reservoir 35. When usingalternate inhalation therapy assembly 30, the user receives theprescribed dosage of medicants from canister 32 as approved with MDI 31.A consumer can purchase a standard MDI and canister and use it withinhalation therapy assembly 30 for improved accuracy in dosage and forconvenience purposes. Connector 33 may have other possibly uses, such aswith a military gas mask for emergency medicine delivery in conjunctionwith an approved MDI and canister.

The illustrations and examples provided herein are for explanatorypurposes and are not intended to limit the scope of the appended claims.

I claim:
 1. An inhalation assembly comprising: a collapsible reservoir,said reservoir comprising a flexible wall, an MDI connector, said MDIconnector joined to said collapsible reservoir, a delivery tube, saiddelivery tube joined to said reservoir whereby medicants can passthrough said MDI connector into said reservoir for continued passagethrough said delivery tube to the patient.
 2. The inhalation assembly ofclaim 1 wherein said MDI connector defines an MDI aperture.
 3. Theinhalation assembly of claim 1 wherein said MDI connector defines anaccessory connector aperture.
 4. The inhalation assembly of claim 1wherein said flexible wall is spring supported.
 5. The inhalationassembly of claim 4 wherein said flexible wall is transparent.
 6. Aninhalation assembly for delivering medicants from an MDI to a patientcomprising; an MDI connector, a collapsible reservoir, said reservoircomprising a flexible wall, said. MDI connector attached to saidcollapsible reservoir, a terminal one-way valve, said terminal one-wayvalve In communication with said collapsible reservoir, a delivery tube,a proximal one-way valve, said delivery tube connected to saidcollapsible reservoir through said proximal one-way valve, means toconnect a patient, said connecting means attached to said delivery tube,and an exhalation valve, said exhalation valve connected to saiddelivery tube.
 7. The inhalation assembly of claim 6 wherein deliverytube is T-shaped and said exhalation valve in axial alignment along saiddelivery tube with said collapsible reservoir.
 8. The inhalationassembly of claim 7 wherein said flexible wall is spring supported. 9.The inhalation assembly of claim 8 wherein said flexible wall istransparent.